Medical Affairs - II

Key Responsibilities

• May assist in the review of study-related and essential start-up documents, as delegated by the study manager, including clinical protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, case report forms, CRF completion guidelines, and other relevant study plans and charters.
• With guidance, plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study team.
• Supports activities associated with out-of-specification programs, expanded access programs, and single-patient IND requests, including coordination of timelines, documentation, communications, and cross-functional follow-up.
• Manages vendors and works with multiple contract research organizations and external partners to communicate detailed timelines, oversee transferred obligations, and ensure performance expectations are met; provides corrective instruction as needed when expectations are not met.
• Attends internal team meetings and other required meetings to support program planning, issue resolution, and execution.
• Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconferences.
• Creates and reviews site feasibility assessments required for participation, where applicable.
• Manages and tracks key deliverables such as screening, enrollment, data flow, protocol deviations, and other program milestones.
• Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior management.
• Prepares metrics and status updates on key deliverables for management review.
• Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicable.
• Prepares site newsletters and other correspondence related to clinical trial or program conduct, including best practices, lessons learned, and frequently asked questions, in collaboration with the study team.
• Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to ICH Google Cloud Platform, study protocols, and applicable treatment-use requirements.
• May participate in special projects and other duties as assigned.
• Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational execution.

Basic Qualifications

• BS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experience.

Preferred Qualifications

• Oncology/hematology experience preferred; cellular therapy experience is a plus.
• Experience with iMedidata/RAVE EDC is a plus.
• Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role is a plus.
• Ability to manage competing time demands, incomplete information, and unexpected events.
• Strong analytical and problem-solving skills.
• High attention to detail.
• Outstanding organizational skills with the ability to multitask and prioritize effectively.
• Excellent interpersonal, verbal, and written communication skills in a collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
• Working knowledge of transplant patient care and apheresis collection is a plus.